Cardiac ArrhythmiaKODEXNCT04552665
Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance.
An observational study of Cardiac Arrhythmia, run by EPD Solutions, A Philips Company at 1 site in United States.
Trial summary
The purpose of the KODEX EPD Field study is to evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D) related to the KODEX-EPD system, as well as for marketing and publication purposes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- KODEX-EPD system
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2020to 6 Jun 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo a cardiac ablation
Who may be able to join
- Cardiac Ablation
Who cannot join
- There is no exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital North Campus
Staten Island, New York, 10305
About this study
Official title: Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance
The purpose of the KODEX EPD Field study is to evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D) related to the KODEX-EPD system, as well as for marketing and publication purposes. The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.
- Conditions
- Cardiac Arrhythmia
- Being tested
- KODEX-EPD system
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KODEX-EPD systemDevice
To evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D)
| Study group | Role | What they receive |
|---|---|---|
| Adults | Patients who have cardiac arrhythmia Receives: Device: KODEX-EPD system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Images
The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.
Measured: Through study completion, an average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start28 Oct 2020
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Why it stopped: EPD Business was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- EPD Solutions, A Philips Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Marcin Kowalski, MD, Principal investigator, Staten Island University Hospital NorthAnneleen Viville, Study director, EPD Solutions, A Philips Compagny
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552665
- Sponsor's protocol ID
- 20-0337
- Acronym
- KODEX
- Status last verified
- Jun 2023
- First submitted
- 18 Aug 2020
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance
- ClinicalTrials.gov ID
- NCT04552665
- Acronym / sponsor ID
- KODEX / 20-0337
- Conditions
- Cardiac Arrhythmia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: EPD Business was terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EPD Solutions, A Philips CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Philips Healthcare
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the KODEX EPD Field study is to evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D) related to the KODEX-EPD system, as well as for marketing and publication purposes. The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Device: KODEX-EPD systemPatients who have cardiac arrhythmia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo a cardiac ablation
Key inclusion criteria (1 listed)
- Cardiac Ablation
Key exclusion criteria (1 listed)
- There is no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KODEX-EPD systemTo evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D) | Device | Adults |
Primary outcome
Cardiac Images
Time frame: Through study completion, an average 1 year
The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.
Results and safety
The study was stopped early (reason given: EPD Business was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Kowalski, MD principal investigator
Staten Island University Hospital North
Anneleen Viville study director
EPD Solutions, A Philips Compagny
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by EPD Solutions, A Philips Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: EPD Business was terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Images (time frame: Through study completion, an average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.